midazolam in sodium chloride

Generic: midazolam in sodium chloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midazolam in sodium chloride
Generic Name midazolam in sodium chloride
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

midazolam hydrochloride 1 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-618
Product ID 68083-618_fda891ec-dee1-4978-a550-8c10c1cf3d8c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218993
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-08-12

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083618
Hyphenated Format 68083-618

Supplemental Identifiers

RxCUI
2541170 2541171
UPC
0368083619015 0368083618018
UNII
W7TTW573JJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name midazolam in sodium chloride (source: ndc)
Generic Name midazolam in sodium chloride (source: ndc)
Application Number ANDA218993 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 POUCH in 1 CARTON (68083-618-10) / 1 BAG in 1 POUCH / 50 mL in 1 BAG
source: ndc

Packages (1)

68083-618-10 10 POUCH in 1 CARTON (68083-618-10) / 1 BAG in 1 POUCH / 50 mL in 1 BAG

Ingredients (1)

midazolam hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Midazolam In Sodium Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fda891ec-dee1-4978-a550-8c10c1cf3d8c", "openfda": {"upc": ["0368083619015", "0368083618018"], "unii": ["W7TTW573JJ"], "rxcui": ["2541170", "2541171"], "spl_set_id": ["9ba78a7c-5b05-42a3-89cd-ca51ad9b2e6d"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (68083-618-10)  / 1 BAG in 1 POUCH / 50 mL in 1 BAG", "package_ndc": "68083-618-10", "marketing_start_date": "20240812"}], "brand_name": "Midazolam In Sodium Chloride", "product_id": "68083-618_fda891ec-dee1-4978-a550-8c10c1cf3d8c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "68083-618", "dea_schedule": "CIV", "generic_name": "Midazolam In Sodium Chloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midazolam In Sodium Chloride", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA218993", "marketing_category": "ANDA", "marketing_start_date": "20240812", "listing_expiration_date": "20261231"}